Social & Behavioral Rhythms in Chronic Pain

NCT03022643 | Completed DMC

• 1 other identifier: 094507
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Behavioral and biological rhythms are essential for health. No study evaluated behavioral rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective of this study is to gather preliminary data, focusing on the role of behavioral rhythms in the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood). Additionally, this study will provide preliminary data for the feasibility and acceptability of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Activity Rhythms - Actigraphy Assessment

  Collected continuously for 8 days at baseline

  Baseline

• Change in Activity Rhythms - Actigraphy Assessment

  Collected continuously for 8 days at baseline, at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

Secondary Outcomes (11)

• Insomnia Severity index

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

• Social Rhythms Metric

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

• Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

• Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment

  Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

Study Arms (3)

Pain Patients

NO INTERVENTION

40 Pain Patients will be screened for social and behavioral rhythms with no treatment involved. All patients will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.

Controls

NO INTERVENTION

40 Controls will be screened for social and behavioral rhythms with no treatment involved. All Controls will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.

Treatment

EXPERIMENTAL

10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.

Behavioral: Interpersonal Social Rhythms Psychotherapy; Other: Bright Light Device

Interventions

Interpersonal Social Rhythms Psychotherapy BEHAVIORAL

The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.

Treatment

Bright Light Device OTHER

All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.

Also known as: Re-Timer

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants (patients and controls):
• years of age with
• reading/writing proficiency in English.
• Aim 1:
• Patients must:
• have had persistent pain for more than 1-year at a consistent body part or diffuse body pain (e.g., fibromyalgia) that is stable rather than progressive in nature
• report experiencing pain for more than 70% of the waking hours in any given week
• under current medical care by a physician for a pain diagnosis
• able remain stable on any of their medication (as prescribed) for the duration of the 8-day evaluation involved in Aim 1
• Control subjects must:
• be pain-free for the past 1-year
• no prior treatment for a chronic pain condition
• in overall good health
• Aim 2:
• Patients must:

You may not qualify if:

• Aim 1:
• patients/controls who underwent surgery in the last 6-months
• shift workers
• dementia
• current drug abuse/dependence
• receiving treatment in methadone clinic
• current cardiac conditions
• untreated sleep apnea
• untreated restless legs syndrome
• neurodegenerative disease
• bipolar disorder
• psychosis
• suicidal ideation
• have changed time-zones in the last 7 days
• experienced a significant life change in the last month (e.g., death in the family, loss of job, traumatic event)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariel B Neikrug, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: January 16, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)